1 Scope
This part of GB/T 16886 provides general requirements for evaluating the interactions of medical devices with blood. It describes
a) classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in GB/T 16886.1/ISO 10993-1;
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This part of GB/T 16886 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 16886.1-2001 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing (idt ISO 10993-1: 1997)
GB/T 16886.2-2000 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements (idt ISO 10993-2: 1992)
3 Terms and Definitions
For the purposes of this part of GB/T 16886, the terms and definitions given in GB/T 16886.1/ISO 10993-1 and the following apply.
Foreword i
Introduction iii
1 Scope
2 Normative References
3 Terms and Definitions
4 Abbreviated Terms
5 Types of Device in Contact with Blood (As Categorized in GB/T 16886.1/ISO 10993-1)
6 Characterization of Blood Interactions
Annex A (Informative) Preclinical Evaluation of Cardiovascular Devices and Prostheses
Annex B (informative) Laboratory Tests: Principles, Scientific Basis and Interpretation
Annex C (informative) Evaluation of Haemolytic Properties of Medical Devices and Their Components
Bibliography
